NCT04993352

Evaluate the Safety and Efficacy of HLX04-O in Subjects With wAMD

A Phase I/II, Single-arm, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of HLX04-O Administered by Intravitreal Injection in Subjects With Wet Age Related Macular Degeneration (wAMD)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HLX04-O administered every 4 weeks in participants with wet age-related macular degeneration (wAMD)

Detailed description

This is a Phase I/II, Single-arm, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of HLX04-O Administered by Intravitreal Injection in Subjects with wet Age related Macular Degeneration (wAMD).The study will be conducted in approximately 6 sites in China.

Conditions

• Age Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection	0.05mL (12.5mg/0.5mL/vial) HLX-04-O solution at a 4-week interval for intravitreal injection

Timeline

• Start date: 2021-07-15
• Primary completion: 2022-07-07
• Completion: 2023-03-13
• First posted: 2021-08-06
• Last updated: 2023-10-23

Locations

1 site across 1 country: China